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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02164864




Registration number
NCT02164864
Ethics application status
Date submitted
13/06/2014
Date registered
17/06/2014
Date last updated
31/07/2018

Titles & IDs
Public title
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Scientific title
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
Secondary ID [1] 0 0
2013-003201-26
Secondary ID [2] 0 0
1160.186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Percutaneous Coronary Intervention 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dabigatran Etexilate 110mg
Treatment: Drugs - Warfarin 3mg
Treatment: Drugs - Aspirin
Treatment: Drugs - Dabigatran Etexilate 150mg
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Warfarin 5mg
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Warfarin 1mg

Experimental: Dabigatran Etexilate 110mg - Patient to receive Dabigatran Etexilate 110mg twice a day (BID)

Experimental: Dabigatran Etexilate 150mg - Patient to receive Dabigatran Etexilate 150mg twice a day (BID)

Active comparator: Warfarin - Warfarin doses to maintain INR


Treatment: Drugs: Dabigatran Etexilate 110mg
Active treatment

Treatment: Drugs: Warfarin 3mg
Active comparator

Treatment: Drugs: Aspirin
Active comparator

Treatment: Drugs: Dabigatran Etexilate 150mg
Active treatment

Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator

Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator

Treatment: Drugs: Warfarin 5mg
Active comparator

Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator

Treatment: Drugs: Warfarin 1mg
Active comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Adjudicated ISTH MBE or CRNMBE
Timepoint [1] 0 0
up to 30 months
Secondary outcome [1] 0 0
Time to Adjudicated Undetermined Cause of Death
Timepoint [1] 0 0
up to 30 months
Secondary outcome [2] 0 0
Time to Adjudicated Non-CV
Timepoint [2] 0 0
up to 30 months
Secondary outcome [3] 0 0
Time to Adjudicated CV
Timepoint [3] 0 0
up to 30 months
Secondary outcome [4] 0 0
Time to Adjudicated All Cause Death
Timepoint [4] 0 0
up to 30 months
Secondary outcome [5] 0 0
Time to First Adjudicated MI
Timepoint [5] 0 0
up to 30 months
Secondary outcome [6] 0 0
Time to First Adjudicated Stroke
Timepoint [6] 0 0
up to 30 months
Secondary outcome [7] 0 0
Time to First Adjudicated SE
Timepoint [7] 0 0
up to 30 months
Secondary outcome [8] 0 0
Time to First Adjudicated ST
Timepoint [8] 0 0
up to 30 months
Secondary outcome [9] 0 0
Time to Composite Endpoint of Death + MI + Stroke
Timepoint [9] 0 0
up to 30 months
Secondary outcome [10] 0 0
Time to Composite Endpoint of Death or First Thrombotic Event
Timepoint [10] 0 0
up to 30 months
Secondary outcome [11] 0 0
Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
Timepoint [11] 0 0
up to 30 months
Secondary outcome [12] 0 0
Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
Timepoint [12] 0 0
up to 30 months

Eligibility
Key inclusion criteria
Inclusion criteria:

* Male or female patients aged >=18 years
* Patients with Non Valvular Atrial Fibrillation
* Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

* The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Patients with a mechanical or biological heart valve prosthesis
* Cardiogenic shock during current hospitalisation
* Stroke within 1 month prior to screening visit
* Patients who have had major surgery within the month prior to screening
* Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
* Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
* Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
* Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
* Active liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/06/2017
Sample size
Target
Accrual to date
Final
2725
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pendlebury Research - Adamstown
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Heartcare Victoria - Bundoora
Recruitment hospital [8] 0 0
The Geelong Hospital - Geelong
Recruitment postcode(s) [1] 0 0
2289 - Adamstown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3083 - Bundoora
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment outside Australia
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Fukuoka, Kurume
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Gunma, Maebashi
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Hokkaido, Sapporo
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Kagawa, Takamatsu
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Kyoto, Kyoto
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Miyazaki, Miyazaki
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Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
Trial website
https://clinicaltrials.gov/study/NCT02164864
Trial related presentations / publications
Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.
De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.
Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.
Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.
Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.
Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02164864